Early Imaging Biomarkers in NSCLC
Early Imaging Biomarkers to Predict Radiation-Induced Cardiopulmonary Toxicity in Patients With Thoracic Malignancies
2 other identifiers
observational
23
1 country
1
Brief Summary
The purpose of this study is to investigate if cardiac MRI, blood biomarkers, and lung CT scans can detect early changes to the associated with radiation therapy in patients receiving radiation treatment for thoracic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2015
CompletedFirst Submitted
Initial submission to the registry
April 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedAugust 26, 2019
August 1, 2019
3.3 years
April 14, 2017
August 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Lung Function
To characterize longitudinal changes in lung function using a voxel-wise image analysis technique of whole-lung CT scans in patients undergoing intrathoracic radiation therapy.
1 Year post treatment
Secondary Outcomes (4)
Change from Baseline in Myocardial Tissue
1 Year post treatment
Change from Baseline in Myocardial Tissue
1 Year post treatment
Change from Baseline in Myocardial Tissue
1 Year post treatment
Radiation Predictors from Baseline in Cardiopulmonary Changes
1 Year post treatment
Other Outcomes (1)
Radiation Induced Change from Baseline in Imaging
6 month and 1 year post treatment
Study Arms (1)
Lung or Esophageal Patients
Patients with lung or esophageal cancer undergoing conventionally-fractionated radiation therapy. Interventions to be administered include: Imaging Biomarkers using Volumetric CT Scans, Pulmonary using Pulmonary Function Test \& 6Minute Hall Walk, Imaging using Cardiac MRI, Specimen Collection using Blood Draws.
Interventions
Eligibility Criteria
Patients undergoing conventionally-fractionated intrathoracic radiation therapy.
You may qualify if:
- Patients receiving once daily fractionated intrathoracic radiation therapy for:
- Stage IIA-IIIB non-small cell lung cancer
- Limited stage small cell lung cancer
- Stage I-III esophageal cancer (neoadjuvant or definitive)
- Patients must be 18 years of age or older
- Must not be claustrophobic
- Must have adequate kidney function
You may not qualify if:
- Patients with small cell lung cancer receiving twice daily (b.i.d.) radiation
- Patients with esophageal cancer receiving trastuzamab
- Pregnancy or lactation
- Claustrophobia
- Inability to lie flat for 60-90 minutes
- Renal dysfunction with eGFR \<60 mL/min/1.73 m2
- Allergy to gadolinium containing contrast media
- Implanted devices, metallic hazards or other conditions presenting a contraindication to 3Tesla cardiac MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shruti Jolly, MD
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2017
First Posted
April 20, 2017
Study Start
September 23, 2015
Primary Completion
January 1, 2019
Study Completion
January 1, 2019
Last Updated
August 26, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share